Phase I-IIa, randomized, controlled, open-label, single-center clinical trial to evaluate the safety, feasibility, and evidence of efficacy of the use of an autologous tissue-engineered nanostructured fibrin-agarose oral mucosa substitute for human palatal mucosa in the treatment of patients with cleft palate

Phase 1

Recruiting

• Conditions: Cleft lip and palate; MedDRA version: 20.1Level: LLTClassification code: 10024533Term: Lip and palate cleft Class: 10010331; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2023-506913-23-00
• Lead Sponsor: Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Paediatric patients of either sex. 2. Diagnosis of non-syndromic total unilateral cleft lip and palate (FLPNS) who are going to undergo surgery for correction. 3. Children who have previously donated an oral mucosa sample during the cleft lip repair procedure (cheiloplasty). 4. Informed consent signed by one or both parents (or legal guardian) adequately informed of the study and willing to follow the trial procedures and instructions.

Exclusion Criteria

5.Active infectious diseases. 6.Allergies or hypersensitivity to any of the components/excipients of the investigational product. 7.Haematological disorders/severe blood dyscrasias. 8.Severe hepatic or renal dysfunction/insufficiency. 9.Severe endocrine disorders/dysfunction. 10.Malignant neoplasms. 11.Active HIV, HBV or HCV infection. 12.Metabolic bone diseases (Paget's disease, hypercalcaemia, etc.). 13.Children with cleft lip and palate who have other congenital malformations which, in the opinion of the investigator, could affect the outcome of the study or the interpretation of the study results. 14.Any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the safety and feasibility of using an autologous tissue-engineered nanostructured fibrin-agarose human palatal mucosa substitute in the treatment of cleft palate;Secondary Objective: Use of BIOCLEFT in the treatment of patients with cleft palate, evaluating the clinical evolution of some parameters, in comparison with the control group: regeneration and healing; aesthetic appearance; craniofacial growth; hearing evaluation; speech therapist and quality of life;Primary end point(s): Feasibility: if in at least 3 of the 5 patients in the initial phase it can be verified that the surgical implantation of the BIOCLEFT has been carried out satisfactorily; Safety: occurrence of any adverse event, serious or non-serious, and specifically, those adverse events and serious adverse events related to treatment and indications of efficacy regeneration and healing; aesthetic appearance; craniofacial growth; hearing evaluation; speech therapist and quality of life